Medical Director

About Us

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science‑led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world‑class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work‑life balance, CenExel Clinical Research also provides highly competitive compensation.

Benefits

Full‑time employees receive a generous benefits package after 30 days of employment, including:

• Health Insurance
• Dental
• Vision
• Long‑Term Disability (LTD)
• Short‑Term Disability (STD)
• Life Insurance
• 401(k) retirement plan

Job Summary

The Medical Director assumes site responsibility other than those responsibilities specifically intended for the PI. This role ensures adherence to protocol requirements, protects the rights and welfare of participants, assures the integrity of data generated at the site, and directs the conduct of the clinical investigation according to federal and state regulations and guidance documents.

Responsibilities

• Provides medical direction and overall supervision of the medical aspects of the clinical trial site.
• Ensures that safety of study volunteers is not compromised.
• Develops, approves, and implements policies and best practices including continuous quality improvement programs.
• Assists in determining the feasibility of site to execute protocols effectively and efficiently.
• Assists in protocol development when requested by sponsor or CRO.
• Monitors and evaluates implementation and effectiveness of quality programs and assessments.
• Ensures that adequate resources are provided for performance of work and assessment activities.
• Attends management reviews, monthly staff meetings, study initiation meetings, monitoring visits, regulatory and sponsor audits as needed.
• Oversees and trains investigators as needed.
• Provides updates and status reports to owners on a regular basis, reporting on performance against plan.
• Acts as a liaison for the site to external medical providers, the medical community, sponsor, CRO, and inspection agencies.
• Reviews clinical trial protocols and makes recommendations as necessary.
• Interviews and hires new staff as needed.
• Participates in communications, support, and provides insight for projects including staffing, timelines, and key data issues.
• Hires, trains, supervises, and evaluates personnel.
• Champions and enforces strict adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies.
• Retrains and implements corrective and preventative actions, as needed.
• Assumes other duties and responsibilities as assigned.

Qualifications

• Must be able to effectively communicate verbally and in writing.
• Licensed MD or relevant experience that translates to a Doctorate degree.
• At least two years of clinical trial management and oversight required.
• Must be self‑directed and able to work with minimal supervision.
• In‑depth knowledge of FDA regulations.
• Able to take a flexible approach to shifting priorities.
• Able to manage multiple projects and responsibilities.
• Motivated to work consistently in a fast‑paced and rapidly changing environment.

Working Conditions

• Indoor, office environment.
• Essential physical requirements include sitting, typing, standing, and walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work as scheduled is essential.
• On‑site work arrangement.
• Occasional travel.